[31 Pa.B. 3043]
[Continued from previous Web Page] § 9.707. External grievance process.
(a) The plan shall establish and maintain an external grievance process by which an enrollee, or a health care provider with the written consent of the enrollee, may request an external review of a denial of a second level grievance following receipt of the second level grievance review decision.
(b) The external grievance process shall adhere to the following standards:
(1) An enrollee, the enrollee's representative or the health care provider who filed the grievance shall have 15 days from receipt of the second level grievance review decision to file a request for an external review with the plan. If the request for an external grievance is being filed by a health care provider, the health care provider shall provide the name of the enrollee involved and a copy of the enrollee's written consent for the health care provider to file the grievance.
(2) Within 5 business days of receiving the external grievance from the enrollee or a health care provider filing a grievance with enrollee consent, the plan shall notify the Department, the enrollee and the health care provider if the health care provider has filed the grievance with enrollee consent, and a CRE that conducted the internal grievance review that a request for an external grievance review has been filed.
(3) The plan's notification to the Department shall include a request for assignment of a CRE.
(4) Along with notification and the request for assignment of a CRE, and the information in paragraph (5), the plan shall provide the Department with the name, title and phone numbers of both a primary and alternative external grievance coordinator. One of these individuals shall be available to the Department so that expeditious communication may be had regarding the assignment of a CRE both for the purpose of performing external grievance reviews and of tracking the status of such reviews.
(5) The plan's request to the Department for assignment of a CRE shall include the following:
(i) The enrollee's name, address and telephone number.
(ii) If the request for an external grievance is being filed by a health care provider, identifying information for that provider, and a copy of the enrollee's written consent to the health care provider to file the grievance.
(iii) The name of the plan.
(iv) The enrollee's plan identification number.
(v) The enrollee's appeal from the second level grievance review decision.
(vi) A copy of the decision of the second level review committee.
(vii) Correspondence from the plan relating to the matter in question.
(viii) Other reasonably necessary supporting documentation, which may include UR criteria, technology assessments, care notes, information submitted by clinicians regarding the enrollee's health status as it relates to the matter being reviewed, opinions from specialists in a same or similar specialty or peer reviewers and information submitted by the enrollee, the enrollee's representative and the treating health care providers.
(ix) If the external grievance is being requested by a health care provider, verification that the plan and the health care provider have both established escrow accounts in the amount of half the anticipated cost of the review.
(6) Within 15 days of receipt of the request for an external grievance review, the plan shall forward to the CRE assigned to perform the external grievance review the written documentation regarding the denial, including the following:
(i) The decision.
(ii) All reasonably necessary supporting information.
(iii) A summary of applicable issues.
(iv) The contractual language supporting the denial including the plan's definition of ''medical necessity'' used in the internal grievance reviews.
(7) Within the same 15-day period as provided by paragraph (6), the plan shall provide the enrollee, the enrollee's representative, or the health care provider if the health care provider filed the grievance with consent, with the list of documents being forwarded to the CRE for the external review.
(8) The enrollee, the enrollee's representative, or the health care provider if the health care provider filed the grievance with enrollee consent, within 15 days of receipt of notice that the request for an external grievance review was filed with the plan, may supply additional information to the CRE for consideration in the external review but shall simultaneously provide copies of the information to the plan so that the plan has an opportunity to consider the additional information.
(c) Within 2-business days of receiving a request for an external grievance review, the Department will assign a CRE from its list of approved CREs on a rotation basis and will provide notice of the CRE assignment to the plan, the enrollee and the enrollee's representative, the health care provider, if the grievance was filed with enrollee consent, and the CRE.
(d) The Department will make available additional information from the CRE's accreditation application to the plan, the enrollee and the enrollee's representative, or the health care provider that filed a grievance with enrollee consent upon request. The Department will include in the notice issued under subsection (c), instructions on how to contact the Department for this information.
(e) If the Department fails to select a CRE within 2 business days of receipt of a request for an external grievance review, the plan may designate a CRE to conduct a review from the list of CREs approved by the Department. The plan may not select a CRE that has a current contract or is negotiating a contract with the plan or its affiliates to perform UR, or is otherwise affiliated with the plan or its affiliates to conduct the external grievance review.
(f) Each party has 7 business days from the date on the notice of assignment of the CRE to object orally or in writing to the Department about the CRE assigned whether the CRE has been assigned by the Department, or designated by the plan under subsection (e) based on conflict of interest. For purposes of this section, conflict of interest shall mean that the CRE has or is proposing to enter into a contract with the plan or an affiliate of the plan to perform UR, or is otherwise affiliated with the plan or its affiliates. The objecting party may request the assignment of another CRE.
(g) If a party objects, the Department will assign a second CRE in accordance with subsection (c). The parties may object to the second CRE in accordance with this section.
(h) If either party objects to the second CRE assigned, the 60-day time period allowed for the CRE's review under § 9.708(a) (relating to external grievance reviews by CREs) will be calculated from the date on which the CRE is accepted by both parties.
(i) The Department will assign a uniform tracking number, which shall be utilized by the plan, CRE, enrollee and the enrollee's representative, and health care provider who filed the grievance with enrollee consent to communicate with or report data to the Department.
(j) The plan shall authorize a health care service and pay a claim determined to be medically necessary and appropriate by the CRE whether or not the plan has appealed the CRE's decision to a court of competent jurisdiction.
(k) If the CRE's decision in an external grievance review filed by a health care provider is against the health care provider in full, the health care provider shall pay the fees and costs associated with the external grievance. Regardless of the identity of the grievant, if the CRE's decision is against the plan in full or in part, the plan shall pay the fees and costs associated with the external grievance review. If the enrollee or the enrollee's representative files an external grievance, and the plan prevails, the plan shall pay the fees and costs. For purposes of this section, fees and costs do not include attorney's fees.
§ 9.708. External grievance reviews by CREs.
(a) The assigned CRE shall review and issue a written decision within 60 days of the filing of the request for an external grievance review. The decision shall be sent to the enrollee and the enrollee's representative, the health care provider, if the health care provider filed the grievance with enrollee consent, the plan, and the Department. The decision shall include the credentials of the individual reviewer, a list of the information considered in reaching the decision, the basis and clinical rationale for the decision, a brief statement of the decision, and the statement that the enrollee, and the enrollee's representative, or the health care provider have 60 days from receipt of the decision to appeal to a court of competent jurisdiction.
(b) The assigned CRE shall review the second level grievance review decision based on whether the health care service denied by the internal grievance process is medically necessary and appropriate under the terms of the plan.
(c) The assigned CRE shall review all information considered by the plan in reaching any prior decision to deny coverage for the health care service in question, and information provided in § 9.707 (relating to external grievance process).
(d) The assigned CRE's decision shall be made by either of the following:
(1) One or more physicians certified by a board approved by the American Board of Medical Specialties or the American Board of Osteopathic Specialties, practicing within the same or similar specialty that typically manages or recommends treatment for the health care service being reviewed.
(2) One or more licensed physicians or approved licensed psychologists in active clinical practice in the same or similar specialty that typically manages or recommends treatment for the health care service being reviewed.
(e) In reviewing a grievance decision relating to emergency services, the CRE shall utilize the emergency service standards of Act 68 and this chapter, the prudent layperson standard and the enrollee's certificate of coverage.
§ 9.709. Expedited review.
(a) A plan shall make an expedited review procedure available to enrollees if the enrollee's life, health or ability to regain maximum function would be placed in jeopardy by delay occasioned by the review process in this subchapter.
(b) An enrollee may request from the plan an expedited review at any stage of the plan's review process if the enrollee's life, health or ability to regain maximum function would be placed in jeopardy by delay occasioned by the review process in this subchapter.
(c) In order to obtain an expedited review, an enrollee shall provide the plan with a certification, in writing, from the enrollee's physician that the enrollee's life, health or ability to regain maximum function would be placed in jeopardy by delay occasioned by the review process in this subchapter. The certification shall include a clinical rationale and facts to support the physician's opinion. The plan shall accept the physician's certification, and provide an expedited review.
(d) The plan's internal expedited review process shall be bound by the same rules and procedures as the second level grievance review process with the exception of the following:
(1) The time frames.
(2) The requirements of § 9.705(c)(2)(iii)(b), (c) and (i) (relating to internal grievance process). If the plan cannot accommodate the enrollee as to time and distance, or have the committee physically present at the review, the plan shall hold the hearing telephonically and ensure that all information presented at the hearing is read into the record.
(3) The requirements of § 9.705(c)(3)(iii) with respect to providing the report 7 days prior to the review. The plan shall provide a copy of the report to the enrollee prior to the hearing if possible. If not, the plan may read the report into the record at the hearing, and shall provide the enrollee with a copy of the report at that time.
(4) It is the responsibility of the enrollee or the health care provider to provide information to the plan in an expedited manner to allow the plan to conform to the requirements of this section.
(e) A plan shall conduct an expedited internal review and issue its decision within 48 hours of receipt of the enrollee's request for an expedited review accompanied by a physician's statement in accordance with subsection (c).
(f) The notification to the enrollee shall state the basis for the decision, including any clinical rationale, and the procedure for obtaining an expedited external review.
(g) The enrollee has 2 business days from the receipt of the expedited internal review decision to contact the plan to request an expedited external review.
(h) Within 24 hours of receipt of the enrollee request for an expedited external review, the plan shall submit a request for an expedited external review to the Department by Fax transmission or telephone call. The Department will make information available to the plan to enable the plan to have direct access to a CRE on weekends and State holidays.
(i) The Department will assign a CRE within 1 business day of receiving the request for an expedited review.
(j) When assigning a CRE, the Department will rely on information provided by the CRE as to any affiliations or contractual relationships with plans so as to avoid conflicts of interest.
(k) In all cases, the plan shall transfer a copy of the case file to the CRE for receipt on the next business day and the CRE shall have 2 business days to issue a decision.
§ 9.710. Approval of plan enrollee complaint and enrollee and provider grievance systems.
(a) The Department will review the plan's enrollee complaint and grievance systems under its authority to review the operations of the plan and its quality assurance systems, and complaint and grievance resolution systems to ensure that they meet the requirements of Act 68 and this chapter.
(b) If changes are made by the plan that have the potential to impact the complaint or grievance process or the outcome of cases, the plan shall submit a copy of the proposed changes to the Department for prior review 60 days before the plan intends to implement the changes.
(c) Complaint and grievance procedures for special populations, such as Medicaid and Medicare HMO enrollees, shall comply with Act 68 to the extent permitted by Federal law and regulation.
§ 9.711. Informal dispute resolution systems and alternative dispute resolution systems.
(a) Informal dispute resolution systems.
(1) A plan and a health care provider may agree to an informal dispute resolution system for the review and resolution of disputes between the health care provider and the plan. These disputes include denials based on procedural errors and administrative denials involving the level or types of health care service provided.
(2) Procedural errors and administrative denials in which the enrollee is held financially harmless by virtue of the provider contract or when the enrollee has never been advised by the plan in writing that continued health care services would not be covered benefits, will not be automatically viewed as grievances for the purposes of this subchapter and may be addressed by informal dispute resolution systems.
(3) The informal dispute resolution system agreed upon by the plan and its providers shall be included in the health care provider contract with the plan, and shall be enforceable.
(b) Alternative dispute resolution systems.
(1) To be acceptable to the Department, an alternative dispute resolution system shall:
(i) Be impartial.
(ii) Include specific and reasonable time frames in which to initiate appeals, receive written information, conduct hearings and render decisions.
(iii) Provide for final review and determination.
(2) An alternative dispute resolution system agreed upon by a plan and its participating providers shall be included in the health care provider contracts and shall be final and binding on both the plan and the health care provider.
(3) An alternative dispute resolution system may not be used for any extenal grievance filed by an enrollee.
Subchapter J. HEALTH CARE PROVIDER CONTRACTS Sec.
9.721. Applicability. 9.722. Plan and health care provider contracts. 9.723. IDS. 9.724. Plan-IDS contracts. 9.725. IDS-provider contracts. § 9.721. Applicability.
This subchapter shall apply to provider contracts between plans subject to Act 68 and health care providers; plans and IDSs; and IDSs and health care providers.
§ 9.722. Plan and health care provider contracts.
(a) A plan shall submit the standard form of each type of health care provider contract, including any document incorporated by reference into that contract, to the Department for review and approval. The plan shall be responsible for assuring that the provider contract meets the requirements of all applicable laws. The Department will review a provider contract within 45 days of receipt of the contract. If the Department does not approve or disapprove the contract within 45 days of receipt, the plan may use the contract and it shall be presumed to meet the requirements of all applicable laws. If, at any time, the Department finds that a contract is in violation of law, the plan shall correct the violation.
(b) The plan shall submit any material change or amendment to a standard health care provider contract, including a material change or amendment to any document incorporated by reference into the contract, to the Department 10 days before implementation of the change or amendment except for changes required by law or regulation.
(c) To be approved by the Department, a standard health care provider contract may not contain provisions permitting the plan to sanction, terminate or fail to renew a health care provider's participation for any of the following reasons:
(1) Advocating for medically necessary and appropriate health care services for an enrollee.
(2) Filing a grievance on behalf of and with the written consent of an enrollee, or helping an enrollee to file a grievance.
(3) Protesting a plan decision, policy or practice the health care provider believes interferes with its ability to provide medically necessary and appropriate health care.
(4) Taking another action specifically permitted by sections 2113, 2121 and 2171 of the act (40 P. S. §§ 991.2113, 991.2121 and 991.2171).
(d) To be approved by the Department, a standard health care provider contract may not contain any provision permitting the plan to penalize or restrict a health care provider from discussing any of the information health care providers are permitted to discuss under section 2113 of the act or other information the health care provider reasonably believes is necessary to provide to an enrollee full information concerning the health care of the enrollee.
(e) To be approved by the Department, a standard health care provider contract shall include the following consumer protection provisions:
(1) Enrollee hold harmless language which survives the termination of the health care provider contract regardless of the reason for termination, and includes the following:
(i) A statement that the hold harmless language is construed for the benefit of the enrollee.
(ii) A statement that the hold harmless language supersedes any written or oral agreement currently in existence, or entered into at a later date, between the health care provider and enrollee, or persons acting in their behalf.
(iii) If the provider contract is a contract that affects plan enrollees, language to the following effect:
''In no event including, but not limited to, non-payment by the plan, plan insolvency, or a breach of this contract, shall the provider bill, charge, collect a deposit from, seek compensation or reimbursement from, or have any recourse against the enrollee or persons other than the plan acting on the behalf of the enrollee for services listed in this agreement. This provision does not prohibit collecting supplemental charges or co-payments in accordance with the terms of the applicable agreement between the plan and the enrollee. ''(2) Language stating that enrollee records shall be kept confidential by the plan and the health care provider in accordance with section 2131 of the act (40 P.S § 991.2131) and all applicable State and Federal laws and regulations, which include:
(i) Language permitting the Department, the Insurance Department, and, when necessary, the Department of Public Welfare, access to records for the purpose of quality assurance, investigation of complaints or grievances, enforcement or other activities related to compliance with Article XXI, this chapter and other laws of the Commonwealth.
(ii) Language which states that records are only accessible to Department employees or agents with direct responsibilities under subparagraph (i).
(3) Language requiring the health care provider to participate in and abide by the decisions of the plan's quality assurance, UR and enrollee complaint and grievance systems.
(4) Language addressing any alternative dispute resolution systems.
(5) Language requiring the health provider to adhere to State and Federal laws and regulations.
(6) Language concerning prompt payment of claims consistent with the requirements of section 2166 of the act (40 P. S. § 991.2166) and 31 Pa. Code § 154.18 (relating to prompt payment of claims).
(7) Language requiring that if the plan and the health care provider agree to include a termination without cause provision in the contract, neither party shall be permitted to terminate the contract without cause upon less than 60 days prior written notice.
(8) Language requiring the plan to give at least 30 days prior written notice of any changes to contracts, policies or procedures affecting health care providers or the provision or payment of health care services to enrollees, unless the change is required by law or regulation.
(f) To be approved by the Department, a health care provider contract shall satisfy the following:
(1) Include the reimbursement method being used to reimburse a participating provider under the contract. If a provider reimbursement is subject to variability due to economic incentives, including bonus incentive systems, withhold pools or similar systems, the plan shall describe the systems and the factors being employed by the plan to determine reimbursement when the contract is submitted to the Department for review.
(2) Include no incentive reimbursement system for licensed professional health care providers which shall weigh utilization performance as a single component more highly than quality of care, enrollee services and other factors collectively.
(3) Include no financial incentive that compensates a health care provider for providing less than medically necessary and appropriate care to an enrollee.
§ 9.723. IDS.
(a) Standard IDS contracts between the IDS and the plan and between the IDS and the health care provider shall meet the standards of health care provider contracts in § 9.722 (relating to plan and health care provider contracts).
(b) A plan and an IDS entering into an arrangement under this subchapter shall notify the Department in writing in advance of any action which could result in the IDS's participating providers being unavailable to provide covered services to enrollees.
§ 9.724. Plan-IDS contracts.
(a) A plan may contract with an IDS for the provision of care by IDS participating health care providers to plan enrollees. The contract between the plan and the IDS shall be in compliance with the requirements of this subchapter.
(b) The plan shall provide a copy of the IDS contract to the Department for review and approval. An IDS contract not based on an approved standard contract shall be submitted to the Department for review and approval. An IDS contract shall be reviewed by the Department in accordance with § 9.722(a) (relating to plan and health care provider contracts). If the IDS contract is based on a standard form contract, the plan shall provide the Department with notice of the contract, including the name, address and description of the IDS, before the effective date of the contract.
(c) The plan shall submit the IDS's standard provider contract to the Department for review and approval before the effective date of the IDS contract. If an IDS's providers have executed plan-provider contracts instead of IDS-provider contracts, the plan shall provide the Department with written notice of those contracts before the effective date of the IDS contract.
(d) For the Department to approve a contract between the plan and the IDS, the contract must meet the following standards:
(1) An IDS, assuming financial risk from a plan, is not required to obtain its own license to assume the risk, provided that the ultimate responsibility for benefits and services to enrollees, as set forth in the enrollee contract, remains the responsibility of the plan.
(2) If a person or entity is delivering prepaid basic health care services to enrollees, but not soliciting or enrolling members in a plan, that person or entity is not required to obtain a certificate of authority. If the person or entity is delivering prepaid basic health care services and performing administrative services or other similar functions, but not soliciting or enrolling plan members, that person or entity is not required to obtain a certificate of authority.
(3) The IDS shall acknowledge and agree that under no circumstance shall provision of covered services to enrollees be delayed, reduced, denied or otherwise hindered because of the financial or contractual relationship between the plan and the IDS or between the IDS and the participating health care providers.
(4) The IDS shall acknowledge and agree that only those IDS participating health care providers who meet the plan's credentialing and provider contracting standards may participate and provide services to enrollees and that the ultimate authority to approve or terminate IDS health care providers is retained by the plan.
(5) The IDS shall acknowledge and agree that the plan is required to establish, operate and maintain a health care services delivery system, quality assurance system, provider credentialing system, enrollee complaint and grievance system, and other systems meeting Department standards and that the plan is directly accountable to the Department for compliance with the standards and for provision of quality, cost-effective care to plan enrollees. Nothing in the plan-IDS contract may limit the plan's authority or responsibility to meet standards or to take prompt corrective action to address a quality of care problem, resolve an enrollee complaint or grievance, or to comply with a regulatory requirement of the Department.
(6) The IDS shall agree to provide the plan and the Department with access to medical and other records concerning the provision of services to enrollees by the IDS through its participating health care providers. The IDS shall agree to permit and cooperate with onsite reviews by the Department for purposes of monitoring the effectiveness of the IDS performance of any plan-delegated functions.
(7) The IDS shall agree that any delegation of authority or responsibility, in part or in full, for provider credentialing and relations, quality assessment, UR and other plan functions to the IDS shall be subject to performance monitoring by the plan and Department, and is subject to independent validation by the plan, the Department, or an independent quality review organization or CRE approved by the Department.
(8) The IDS shall agree to collect and provide the plan with utilization, financial and other data for the purposes of monitoring and comparative performance analysis.
(9) The IDS shall agree to comply with data reporting requirements, including encounter, utilization and reimbursement methodology required by the Department.
(10) The IDS shall obtain and maintain Department certification as a CRE if performing UR activities in Subchapter K (relating to CREs) and sections 2151 and 2152 of the act (40 P. S. §§ 991.2151 and 2152).
(11) The IDS contract shall contain enrollee financial hold-harmless provisions acceptable to the Department which prevent the IDS and IDS participating health care providers from billing plan enrollees for covered services (other than authorized copayments, coinsurance, or deductibles) under any circumstances including insolvency of the plan or the IDS.
(12) The IDS contract shall safeguard patient access to care and avoid significant disruption of service delivery by adequately providing for continuation of services by IDS participating health care providers to plan enrollees if the IDS contractual agreement is in any way jeopardized, suspended, terminated or unexpectedly not renewed. In the event of termination, the plan shall ensure continuity of care for those affected enrollees, under Act 68 and § 9.684 (relating to continuity of care).
(13) If the plan and IDS agree to include a termination without cause provision in the contract between the plan and the IDS, neither party shall be permitted to terminate the contract without cause upon less than 60 days prior written notice.
(14) Any delegation of medical management shall meet the requirements of § 9.675 (relating to delegation of medical management).
§ 9.725. IDS-provider contracts.
In addition to the IDS contract, the health care provider contracts between the IDS and its participating health care providers shall be submitted by the plan for review and approval to the Department. For this purpose, the IDS shall provide the plan with a copy of these contracts. To secure Department approval of a contract between the plan and the IDS, an IDS-health care provider contract shall meet the following standards:
(1) The health care provider shall acknowledge and agree that nothing contained in the IDS-provider contract limits the following:
(i) The authority of the plan to ensure the health care provider's participation in and compliance with the plan's quality assurance, utilization management, enrollee complaint and grievance systems and procedures or limits.
(ii) The Department's authority to monitor the effectiveness of the plan's system and procedures or the extent to which the plan adequately monitors any function delegated to the IDS, or to require the plan to take prompt corrective action regarding quality of care or consumer grievances and complaints.
(iii) The plan's authority to sanction or terminate a health care provider found to be providing inadequate or poor quality care or failing to comply with plan systems, standards or procedures as agreed to by the IDS.
(2) An IDS health care provider shall acknowledge and agree that any delegation by the plan to the IDS for performance of quality assurance, utilization management, credentialing, provider relations and other medical management systems shall be subject to the plan's oversight and monitoring of IDS performance.
(3) An IDS health care provider shall acknowledge and agree that the plan, upon failure of the IDS to properly implement and administer the systems, or to take prompt corrective action after identifying quality, enrollee satisfaction or other problems, may terminate its contract with the IDS, and that as a result of the termination, the health care provider's participation in the plan may also be terminated.
(4) The IDS provider contract shall contain enrollee financial hold-harmless provisions acceptable to the Department which prevent the IDS and an IDS participating health care provider from billing plan enrollees for covered services (other than authorized co-payments, coinsurance, or deductibles) under any circumstances including insolvency of the plan or the IDS.
Subchapter K. CREs
CERTIFICATION Sec.
9.741. Applicability. 9.742. CREs. 9.743. Content of an application for certification as a CRE. 9.744. CREs participating in internal and external grievance reviews. 9.745. Responsible applicant. 9.746. Fees for certification and recertification of CREs. 9.747. Department review and approval of a certification request. 9.748. Maintenance and renewal of CRE certification.
OPERATIONAL STANDARDS
9.751. UR system description. 9.752. UR system standards. 9.753. Time frames for UR.
CERTIFICATION § 9.741. Applicability.
(a) Sections 9.742--9.748 of this subchapter set standards for the certification of CREs and the maintenance of that certification.
(b) Sections 9.749--9.751 set operational standards for entities performing UR.
§ 9.742. CREs.
(a) To conduct UR activities, including review of health care services delivered or proposed to be delivered in this Commonwealth for or on behalf of a plan, an entity shall be certified as a CRE by the Department.
(b) Certification shall be renewed every 3 years unless otherwise subjected to additional review, suspended or revoked by the Department. The Department may subject a CRE to additional review, suspend or revoke certification if it determines that the CRE is failing to comply with Act 68 and this chapter.
§ 9.743. Content of an application for certification as a CRE.
(a) A CRE seeking certification shall submit two copies of the Department's application to the Department's Bureau of Managed Care.
(b) The application shall contain the following:
(1) The name, address and telephone number of the applicant as it should appear on the Department's official list of certified CREs.
(2) Information relating to its organization, structure and function, including the following:
(i) The location of the principal office handling UR.
(ii) The articles of incorporation and bylaws, or similar documents regulating the internal affairs of the applicant.
(iii) The name of each owner of more than 5% of the shares of the corporation, if the applicant is a public corporation.
(iv) A chart showing the internal organization of the applicant's management and administrative staff.
(3) The names and resumes of each officer, director and senior management.
(4) A listing of each plan in this Commonwealth for which the applicant currently conducts UR.
(5) A description of the applicant's:
(i) Ability to respond to each telephone call received as required by section 2152 of the act (40 P. S. § 991.2152), including toll-free telephone numbers and the applicant's system to provide access during nonbusiness hours.
(ii) Acceptable selection and credentialing procedures and criteria for physician and psychologist clinical peer reviewers.
(iii) Ability to arrange for a wide range of health care providers to conduct reviews. The applicant shall have access to a pool of clinical peer reviewers sufficient to reasonably assure that appropriately qualified reviewers will be available on a timely basis.
(iv) Procedures for protecting the confidentiality of medical records and certification that the applicant will comply with the confidentiality provisions in section 2131 of the act (40 P. S. § 991.2131) and other applicable State and Federal laws and regulations imposing confidentiality requirements.
(v) Procedures to ensure that a health care provider is able to verify that an individual requesting information on behalf of the plan is a representative of the plan.
(vi) Capacity to maintain a written record of UR decisions adverse to enrollees for at least 3 years, including a detailed justification and all required notifications to the health care provider and enrollee.
(vii) Evidence of approval, certification or accreditation received by a Nationally recognized accrediting body in the area of UR, if it has secured the approval, certification or accreditation.
(viii) The length of time the applicant has been operating in this Commonwealth, if applicable.
(ix) A list of three clients, if any, for which the applicant has conducted UR including the name, address, position and telephone number of a contact person for each client. The Department may contact these references for an assessment of the applicant's past performance and its ability to meet the time frames for prospective, concurrent and retrospective UR in section 2152 of the act (40 P. S. § 991.2152).
(c) The applicant shall certify that decisions resulting in a denial shall be made by:
(1) A licensed physician.
(2) An approved licensed psychologist in a same or similar specialty to the health care provider of the service in question, if the review is of behavioral health care services within the psychologist's scope of practice, and the psychologist's clinical experience provides sufficient experience to review that specific behavioral health care service. A licensed psychologist may not review the denial of payment for a health care service involving inpatient care or a prescription drug.
(d) Compensation from a plan to a CRE, employee, consultant or other person performing UR on its behalf does not contain incentives, direct or indirect, to approve or deny payment for the delivery of any health care service. See section 2152(b) of the act (40 P. S. § 991.2152(B)).
(e) The Department may request additional information from the applicant necessary to review the application for compliance with Act 68 and this chapter.
§ 9.744. CREs participating in internal and external grievance reviews.
(a) To be certified to review internal and external grievances, the applicant shall supply the following additional information to the Department for review, along with the application:
(1) The name and type of business of each corporation, affiliate or other organization that the applicant controls; the nature and extent of the affiliation or control; and a chart or list clearly identifying the relationship between the applicant and affiliates.
(2) The name, title, address and telephone number of a primary and at least one backup designee with whom the Department may communicate regarding assignment of external grievances and other issues.
(3) A disclosure of any known potential conflict of interest which would preclude its review of an external grievance--for example, ownership of or affiliation with a competing plan or other health insurance company.
(4) A description of the applicant's:
(i) Capacity and procedures for notifying the health care provider of additional facts or documents required to complete the UR within 48 hours of receipt of the request for an expedited review.
(ii) Systems and procedures, including staffing and resources, to meet the time frames for decisions as specified in section 2152 of the act (40 P. S. § 991.2152). The applicant shall have access to a pool of clinical peer reviewers sufficient to reasonably assure that appropriately qualified reviewers will be available on a timely basis for internal and external grievance reviews. To be certified, an applicant shall demonstrate it has a contracted and credentialed network of providers, which shall include, at a minimum, all general specialities represented by the American Board Of Medical Specialities (ABMS), the subspecialties of oncology and physician reviewers specializing in transplanation. An applicant shall also provide a description of its ability to obtain within 24 hours the services of a qualified peer reviewer from any speciality or subspecialty required for an external grievance review.
(iii) Capability and agreement to receive and decide all external grievances, or just behavioral health grievances if so desired, and the process for ensuring that clinical peer reviewers, when making an external appeal determination concerning medical necessity, consider the clinical standards of the plan, the information provided concerning the enrollee, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the Federal government, National or professional medical societies, boards and associations.
(iv) The capacity, procedures and agreement to maintain the information obtained in the review of the grievances, including outcomes, for at least 3 years in a manner that is confidential and unavailable to any affiliated entity or person who may be a direct or indirect competitor to the plan being reviewed.
(v) Fee schedule for the conduct of grievance reviews. An applicant will not be certified as a CRE unless the proposed fees for external reviews are determined to be reasonable by the Department.
(5) A certification that the following conditions apply:
(i) The CRE is willing and able to participate on a rotational basis in grievance reviews.
(ii) Internal and external grievances and expedited grievances will be reviewed and processed in accordance with Act 68 and Subchapter I (relating to complaints and grievances).
(b) The Department will add the name of each CRE to its rotational list of CREs certified to conduct external grievances.
§ 9.745. Responsible applicant.
(a) To be certified by the Department, an applicant for certification to perform UR shall be a responsible person.
(1) To make this determination, the Department may review and verify the credentials of any officer, director or member of the management staff of the applicant.
(2) The Department may consider whether any of the officers, directors or management personnel have ever:
(i) Been involved in a bankruptcy proceeding as an officer, director or senior manager of a corporation.
(ii) Been convicted of a state or Federal offense related to health care.
(iii) Been listed by a state or Federal agency as debarred, excluded or otherwise ineligible for state or Federal program participation.
(iv) Been convicted of a criminal offense which would call in to question the individual's ability to operate a CRE.
(v) Had a history of malpractice or civil suits, penalties or judgments against them.
(b) To be determined a responsible person, an applicant shall demonstrate to the Department that it has the ability to perform URs and grievance reviews based on medical necessity and appropriateness, without bias.
§ 9.746. Fees for certification and recertification of CREs.
(a) An entity applying for certification shall include a fee of $1,000 payable to the Commonwealth of Pennsylvania with its application. Applicants seeking certification to perform external grievance reviews shall include an additional $1,000.
(b) The fee for recertification is $500.
§ 9.747. Department review and approval of a certification request.
(a) The Department will review the application for certification as a CRE. If the Department finds deficiencies, it will notify the applicant, identifying the changes required to bring the applicant into compliance.
(b) The Department will have access to the applicant's books, records, staff, facilities and any other information it finds necessary to determine an applicant's compliance with Act 68 and this subchapter. In lieu of a site visit and inspection, the Department may accept accreditation of the applicant by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter.
(c) If the applicant is not accredited by a Nationally recognized accrediting body whose standards are acceptable to the Department, the Department may provide the applicant with the option to undergo an onsite inspection by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter. The cost of the inspection shall be borne by the applicant.
§ 9.748. Maintenance and renewal of CRE certification.
(a) Maintenance. A CRE shall continue to comply with the requirements of Act 68 and this subchapter to maintain its certification. To determine whether a CRE is complying with Act 68 and this subchapter, and is qualified to maintain its certification during the 3-year certification period, the Department may do one or more of the following:
(1) Perform periodic onsite inspections.
(2) Require proof of the CRE's continuing accreditation by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter.
(3) Require an onsite inspection as set forth in § 9.747 (relating to Department review and approval of a certification request).
(b) Renewal.
(1) A CRE shall submit an application for renewal of certification to the Department along with the appropriate renewal fee at least 60 days prior to the expiration of the 3-year certification period.
(2) The renewal application shall include the following:
(i) Evidence of the CRE's continued accreditation by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter.
(ii) A certification that the CRE has complied with and will continue to comply with Act 68 and this subchapter.
(iii) An updating of the CRE's originally filed list of conflicts of interest and CRE contracts with plans.
(iv) A reaffirmation of certifications included in the CRE's original application.
(3) The Department may perform an onsite inspection at the CRE before approving renewal of certification, or may require an onsite inspection set forth in § 9.747.
(c) The Department will have access to the books, records, staff, facilities and other information, including UR decisions, it finds necessary to determine whether a CRE is qualified to maintain its certification in accordance with Act 68 and this chapter.
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